Reported Sep 14, 2022 · Ongoing
Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In…
Abbott Molecular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Molecular, Inc. · 1300 E Touhy Ave · Des Plaines, IL · 60018-3315
Is this the product you have?
- Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.
- Lot codes and dates
- Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.
- Amount recalled
- 579 kits
Where it was sold
Why it was recalled
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
This product could cause temporary or reversible health problems — stop using it.
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