CLASS II ONGOING Device recall · Reported 14 Sep 2022 · FDA Enforcement Report
Abbott Alinity m Sars-CoV-2 Ctrl Kit recalled by Abbott Molecular
Abbott Molecular is recalling Abbott Alinity m Sars-CoV-2 Ctrl Kit, distributed in 24 states. The recall was initiated on 19 Aug 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1679-2022
- FDA event ID
- 90789
- Recalling firm
- Abbott Molecular, Des Plaines, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Aug 2022
- FDA classified
- 6 Sep 2022
- Reported
- 14 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 19 Aug 2022 | Recall initiated by company | |
| 6 Sep 2022 | Classified by FDA | +18 days |
| 14 Sep 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
Product as listed by the FDA
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.
Where it was distributed
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.
ArizonaCaliforniaConnecticutFloridaGeorgiaIllinoisKansasKentuckyLouisianaMassachusettsMichiganMinnesotaMissouriNorth CarolinaNew JerseyNevadaNew YorkOklahomaPennsylvaniaRhode Island
Questions about this recall
Why was it recalled?
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
Which lots are affected?
Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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