FDA DevicesClass II
The product is used for the evaluation of the intrinsic coagulation pathway, APT...
Published: January 21, 2026Recall ID: Z-1095-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for microbial contamination.
Product Description & Identification
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Affected Products
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Additional Source Details
| Field | Value |
|---|---|
| City | Bedford |
| State | MA |
| Event id | 98166 |
| Address 1 | 180 Hartwell Rd |
| Code info | Part Number: 0020006800. UDI-DI: 08426950078920. Lot Number: N1136730. Expiration Date 12/31/2025. |
| Postal code | 01730-2443 |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 7,720 units |
| Reason for recall | Potential for microbial contamination. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251211 |
| Initial firm notification | Letter |
| Center classification date | 20260115 |
Overview
- Recalling FirmInstrumentation Laboratory
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the states of CA, FL, IL, MN, MS, NE, OH, TX, WI and the countries of Belgium, Netherlands, Luxembourg, Switzerland, China, Hong Kong, Israel, Italy, South Korea, Lithuania, Macao, Malaysia, Philippines, Qatar, Romania, Turkey, Kosovo.