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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88930

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

Open FDA event record

Event summary

Timeline bucket
October 13, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Instrumentation Laboratory

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

HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.

Z-0276-2022
Recall number
Z-0276-2022
Initiated
October 13, 2021
Classification
Class II
Status
Ongoing
Quantity
5828 kits (310 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.

Code information

Lot N0705526 UDI: 08426950632887 ***Updated 3/3/22*** Firm has expanded recall to include the following lot: N0806224

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, IA, IL, KS, ME, MI, NC, NY, OK, SC, and VA. The countries of Canada, Chile, China, Costa Rica, Italy, Japan, and South Korea. ***Updated 3/3/22*** Expansion includes states of IN, MN, and NC.