CLASS I ONGOING Device recall · Reported 13 Jul 2022 · FDA Enforcement Report
Nasopharyngeal sample collection tray for Covid-19 testing recalled
American Contract Systems is recalling Nasopharyngeal sample collection tray for Covid-19 testing, labeled as Covid Test Kit, distributed in Minnesota. The recall was initiated on 2 May 2022 and the FDA has classified it as Class I.
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-1277-2022
- FDA event ID
- 90324
- Recalling firm
- American Contract Systems, Kansas City, MO
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 2 May 2022
- FDA classified
- 1 Jul 2022
- Reported
- 13 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 2 May 2022 | Recall initiated by company | |
| 1 Jul 2022 | Classified by FDA | +60 days |
| 13 Jul 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Affected products were assembled off-site by individuals who may not have been properly trained.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Where it was distributed
US distribution in the state of Minnesota.
Questions about this recall
Why was it recalled?
Affected products were assembled off-site by individuals who may not have been properly trained.
Which lots are affected?
UDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221
Where was it sold?
US distribution in the state of Minnesota.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
Other products in this recall event
1 other product · FDA event 90324This product is part of a recall event; the main page for the event is Clean Catch Urine Kit NS 178489, AHMU58A recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Clean Catch Urine Kit NS 178489, AHMU58A recalled | American Contract Systems | Device Malfunction | MN |
More recalls from American Contract Systems
All 210| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Convenience Kits, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, D & C PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | medical procedure kits and trays labeled as: Crani Pack recalled | American Contract Systems | Sterility | IA, MN, MO |
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| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |