FDAFDA · Food and drugs·Recall number Z-1372-2019
Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
Published May 29, 2019 · Recall initiated: January 16, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Polymer Technology Systems, Inc.
- Distributor
- Domestic distribution nationwide.
- Lot
- Q802 Q811 Q813 Q816 Q820 Q823 Q831 Q903
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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