CLASS II ONGOING Device recall · Reported 7 Sep 2022 · FDA Enforcement Report
Architect Stat Troponin-I Reagent Kit recalled by Abbott Laboratories
Abbott Laboratories is recalling Architect Stat Troponin-I Reagent Kit, distributed nationwide in the US. The recall was initiated on 26 Jul 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-1660-2022
- FDA event ID
- 90692
- Recalling firm
- Abbott Laboratories, Abbott Park, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jul 2022
- FDA classified
- 30 Aug 2022
- Reported
- 7 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Jul 2022 | Recall initiated by company | |
| 30 Aug 2022 | Classified by FDA | +35 days |
| 7 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
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
Product as listed by the FDA
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
Which lots are affected?
UDI (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127 Lot lot 63718UN22
Where was it sold?
Nationwide
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.
More recalls from Abbott Laboratories
All 153| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Alinity hq Analyzer recalled by Abbott Laboratories | Abbott Laboratories | Device Malfunction | Nationwide |
| Device | CLASS II | Cell-dyn Ruby recalled by Abbott Laboratories | Abbott Laboratories | Device Malfunction | Nationwide |
| Device | CLASS II | Cell-dyn Ruby recalled by Abbott Laboratories | Abbott Laboratories | Device Malfunction | Nationwide |
| Device | CLASS II | Cell-dyn Ruby recalled by Abbott Laboratories | Abbott Laboratories | Device Malfunction | Nationwide |
| Device | CLASS II | Cell-dyn Ruby recalled by Abbott Laboratories | Abbott Laboratories | Device Malfunction | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,661| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled | Biomerieux | Other | MO |
| Device | CLASS II | DASH Rapid PCR Instrument recalled by Nuclein | Nuclein | Device Malfunction | Nationwide |