Abbott Alinity m SARS-CoV-2 CTRL Kit recall
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.
Why was Abbott Alinity m SARS-CoV-2 CTRL Kit recalled?
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.
- Product
- 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.
- Recalling firm
- Abbott Molecular, Inc.
- Quantity
- 579 kits
- Distribution
- Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OK, PA, RI, TN, TX, WA, and WI. There was government distribution but no military distribution. Foreign distribution was made to Chile and Taiwan.
- Recall date
- September 14, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)