Polymer Technology Systems, Inc.: PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers

Is my product affected?

PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers

• UPC 00381932412018

Check against the official notice below — it lists the full affected range.

What happened

Polymer Technology Systems, Inc. is recalling PTS Panels CHOL+HDL+GLU Test Strips (Lot Number I502) used with CardioChek PA or CardioChek Plus analyzers because the test strips are showing under-recovery when tested against a reference method. The recall affects 6,467 units that were distributed across 16 U.S. states (California, Connecticut, Florida, Indiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee, and Wisconsin) and 8 countries (Australia, Belgium, Indonesia, Italy, Poland, South Africa, the UK, and Vietnam).

The source document does not specify a remedy or recommended course of action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

This lot of test strips is showing an under-recovery when tested against a reference method.

Details from the source

Reason for recall: This lot of test strips is showing an under-recovery when tested against a reference method. Distribution: 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. Quantity: 6467 Lot/code info: Lot Number I502, UDI 00381932412018

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 7010545882016-03-11
• Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 7010649922016-03-11
• eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.2016-03-10
• Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 9 mL, R2 9 mL, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/ml; R1 Two biotinylated monoclonal anti-estradiol antibodies (rabbit) 2.5 ng/m and 4.5 ng/mL Mesterolone 130 ng/mL; R2 Estradiol derivative, label2016-03-07
• Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL, IVD, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/mL; R1 Biotinylated polyclonal anti-estradiol antibody (rabbit) 45 ng/mL; Mesterolone 130 ng/mL; R2 Estradiol derivative, labeled with ruthenium 2016-03-07

All FDA (Device enforcement) recalls