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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61737

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 22, 2012
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Tripath Imaging, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

PrepStain Syringing Pipettes 240 (Catalog #490517)

Z-1811-2012
Recall number
Z-1811-2012
Initiated
March 22, 2012
Classification
Class III
Status
Terminated
Recalling firm
Tripath Imaging, Inc.
Quantity
46,112,784 for all products in Recall Event

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

Code information

100901a, 100902f, 100902f, 100903d, 100908c, 100910c, 100914f, 100916d, 100921d, 100928c, 101005a, 101007d, 101008c, 101012c, 101013a, 101015c, 101020d, 101022c, 101027a, 101028c, 101029d, 101103b, 101105h, 101110f, 101111c, 101117p, 101118n, 101119c, 101130p, 101201o, 101207o, 101208p, 101210c, 101213n, 101214b, 101214c, 101217b, 101220q, 101221g, 110104b, 110106a, 110107c, 110110d, 110112n, 110118b, 110128i, 110203i, 110210r

Distribution pattern

Worldwide Distribution.

device · product 2 of 5

PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523

Z-1812-2012
Recall number
Z-1812-2012
Initiated
March 22, 2012
Classification
Class III
Status
Terminated
Recalling firm
Tripath Imaging, Inc.
Quantity
46,112,784 for all products in Recall Event

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

Code information

100903ra, 100903rb, 100903rf, 100903rj, 100903rn, 100903rr, 100903rt, 100903rx, 100903sb, 100903sc, 100903sd, 100903se, 100903sf, 100903sl, 100910rd, 100910re, 100910rh, 100910rp, 100910rq, 100910rr, 100917rb, 100917rh, 100917rk, 100917rp, 100917rr, 100917ru, 100917sa, 100917sc, 100917se, 100924ra, 100924ri, 100924rj, 100924rl, 100924rn, 100924rp, 100924rs, 100924rt, 100924ry, 101001ra, 101001rb, 101001rc, 101001rh, 101001rm, 101001rq, 101001ru, 101001rv, 101001rw, 101001ry, 101001rz, 101008ra, 101008rb, 101008rf, 101008rg, 101008rh, 101008ri, 101008rq, 101008rr, 101008rw, 101008rx, 101008sa, 101008sc, 101008sd, 101008se, 101008sf, 101008sg, 101008sh, 101015rh, 101015rk, 101015rr, 101015rw, 101015rx, 101015sd, 101015se, 101015sf, 101015sg, 101022re, 101022rp, 101022rq, 101022sb, 101022si, 101022sk, 101022sl, 101022so, 101022sr, 101022su, 101029ra, 101029rd, 101029re, 101029rh, 101029ri, 101029rx, 101029sc, 101029sd, 101029sf, 101029sk, 101029ss, 101029st, 101105rl, 101105rm, 101105rt, 101105sb, 101105sd, 101105se, 101105sf, 101105sk, 101105sl, 101105so, 101105ss, 101112ra, 101112re, 101112rl, 101112rt, 101112ru, 101112rv, 101112rz, 101112sa, 101112sf, 101112sg, 101112si, 101112sw, 101112sx, 101119ra, 101119ri, 101119rj, 101119rr, 101119ru, 101119rx, 101119ry, 101119rz, 101119sh, 101119sl, 101119so, 101126ra, 101126rg, 101126rl, 101203ra, 101203rb, 101203rc, 101203rd, 101203rh, 101203rj, 101203rp, 101203rr, 101203rs, 101203ru, 101203rw, 101203si, 101203sl, 101203sn, 101203so, 101203sp, 101210rg, 101210rh, 101210rk, 101210rl, 101210ru, 101210rv, 101210rx, 101210sa, 101210sj, 101217ra, 101217rc, 101217rh, 101217rm, 101217rn, 101217rp, 101217rt, 101217rw, 101217rx, 101224rd, 101224re, 101224rg, 101224rk, 101224rl, 101224rt, 101224ru, 101224rv, 101224rw, 101231rc, 101231rd, 101231rg, 101231rh, 101231ri, 101231rj, 101231ro, 101231rp, 110107rh, 110107ri, 110107rk, 110107rp, 110107rq, 110107rr, 110107rz, 110107sb, 110107sc, 110114rf, 110114rg, 110114rv, 110114rw, 110114rx, 110114ry, 110114sj, 110114sk, 110114sm, 110121rd, 110121rn, 110121rq, 110128rd, 110128rp, 110128rq, 110128rx, 110128sb, 110128sc, 110128sg, 110128sl, 110128sn, 110128sp, 110128sq, 110204ra, 110204rd, 110204rg, 110204rj, 110204rq, 110204rv, 110204rx, 110204sd, 110211rb, 110211rd, 110211rg, 110211rj, 110211rn, 110218rw, 110225rk, 110225rl, 100917rc, 101015sb, 101119sg, 101217ro, 110114sc, 110128sk

Distribution pattern

Worldwide Distribution.

device · product 3 of 5

PrepStain Installation Kit (PreCoat), Catalog/Model # 490528

Z-1813-2012
Recall number
Z-1813-2012
Initiated
March 22, 2012
Classification
Class III
Status
Terminated
Recalling firm
Tripath Imaging, Inc.
Quantity
46,112,784 for all products in Recall Event

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

Code information

100917ry, 101105sh, 110107rg

Distribution pattern

Worldwide Distribution.

device · product 4 of 5

Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529

Z-1814-2012
Recall number
Z-1814-2012
Initiated
March 22, 2012
Classification
Class III
Status
Terminated
Recalling firm
Tripath Imaging, Inc.
Quantity
46,112,784 for all products in Recall Event

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

Code information

100903ru, 100924rr, 101022sc, 110114sh, 110225ru

Distribution pattern

Worldwide Distribution.

device · product 5 of 5

PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240)

Z-1815-2012
Recall number
Z-1815-2012
Initiated
March 22, 2012
Classification
Class III
Status
Terminated
Recalling firm
Tripath Imaging, Inc.
Quantity
46,112,784 for all products in Recall Event

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

Code information

This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the actual product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240), which are: 100901a, 100902f, 100902f, 100903d, 100908c, 100910c, 100914f, 100916d, 100921d, 100928c, 101005a, 101007d, 101008c, 101012c, 101013a, 101015c, 101020d, 101022c, 101027a, 101028c, 101029d, 101103b, 101105h, 101110f, 101111c, 101117p, 101118n, 101119c, 101130p, 101201o, 101207o, 101208p, 101210c, 101213n, 101214b, 101214c, 101217b, 101220q, 101221g, 110104b, 110106a, 110107c, 110110d, 110112n, 110118b, 110128i, 110203i, 110210r

Distribution pattern

Worldwide Distribution.

Field note

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