Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91611

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

Open FDA event record

Event summary

Timeline bucket
March 16, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
LetsGetChecked 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

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

LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.

Z-1212-2023
Recall number
Z-1212-2023
Initiated
March 16, 2022
Classification
Class II
Status
Ongoing
Recalling firm
LetsGetChecked Inc.
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result, a number of users received sample collection kits that were assigned to another user resulting in a mismatch of user identification. The impact to users is that they may return the sample and obtain potential incorrect Hepatitis C Virus (HCV) results and/or the sample may be rejected due to mismatched demographics resulting in delayed testing and/or treatment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result, a number of users received sample collection kits that were assigned to another user resulting in a mismatch of user identification. The impact to users is that they may return the sample and obtain potential incorrect Hepatitis C Virus (HCV) results and/or the sample may be rejected due to mismatched demographics resulting in delayed testing and/or treatment.

Code information

(UDI): (01)00850024881341(17)240901(10)20391 Lot Number: 20391 Exp. Date: 01Sep2024

Distribution pattern

US Nationwide distribution in the state of Alabama.

Field note

Send feedback

We'll only use this to respond to your feedback.