Clean Catch Urine Kit NS 178489, AHMU58A recallZ-1276-2022 · American Contract Systems, Inc. · initiated May 2, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from American Contract Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Affected products were assembled off-site by individuals who may not have been properly trained.
FDA root cause category: Process control
What the company is doing
On May 2, 2022, the customer was notified by email. The customer was instructed to destroy or discard affected kits.
Recall details
- Recall number
- Z-1276-2022
- Status
- Open, Classified
- Initiated by the company
- May 2, 2022
- Posted by the FDA
- Jul 1, 2022
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 274,400 kits total
- Product code
- JSM
- Distribution
- US distribution in the state of Minnesota.
Product description
Clean Catch Urine Kit NS 178489, AHMU58A
Code information (models, lots, serial numbers)
UDI-DI: 00191072120557 Lots 891211, 737211, 699211, 986221
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ACS AHMU58AAmerican Contract Systems, Inc. · Blood and urine collection kit (excludes HIV testing)1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 90324).
- Z-1277-2022 · Open, ClassifiedNasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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