Device product
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Z-0741-2020
Product summary
- Event
- Event 84264
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6467
- Official record key
device-enforcement:Z-0741-2020
Official wording
Reason: This lot of test strips is showing an under-recovery when tested against a reference method.
Code information: Lot Number I502, UDI 00381932412018
Distribution pattern: The products were distributed to the following US states: CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, and WI. The products were distributed to the following foreign countries: Australia, Belgium, Indonesia, Italy, Poland, South Africa, UK, and Vietnam.
Derived failure modes
-
Unknown
This lot of test strips is showing an under-recovery when tested against a reference method.