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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77152

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 27, 2017
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Randox Laboratories

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

1 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 1

Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.

Z-2167-2017
Recall number
Z-2167-2017
Initiated
April 27, 2017
Classification
Class III
Status
Terminated
Recalling firm
Randox Laboratories
Quantity
198 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. Instrument specific values are correct. This does not affect the performance or stability claims of the product. As control results will be outside of the quoted range this may result in a delay in reporting the sample test results. However as the correct instrument specific means are also included in the value sheet this delay is unlikely. Customers have been referred to their Medical Director for further advice

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. Instrument specific values are correct. This does not affect the performance or stability claims of the product. As control results will be outside of the quoted range this may result in a delay in reporting the sample test results. However as the correct instrument specific means are also included in the value sheet this delay is unlikely. Customers have been referred to their Medical Director for further advice

Code information

Catalogue number UC5075 Batch number 907UC

Distribution pattern

Worldwide Distribution - US Distribution to Puerto Rico and to the countries of : Canada Kuwait Chile Poland China Romania France Saudi Arabia Guatemala Slovenia Iran UAE India UK Italy Uruguay Iraq

Field note

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