Recall Z-1372-2019 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
Polymer Technology Systems, Inc.
Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
| Date | Jan 16, 2019 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Device Design |
| Action | The firm initially notified some of their customers from January through March 2019 with a Customer Bulletin. On March 28, 2019, the firm issued an updated Urgent Medical Device Recall letter to all affected customers. The letter alerted customers to the potential for test strips to slip out of the analyzer. Actions to be taken by the Customer/User: 1. Closely follow the instructions for proper testing. " Make sure the analyzer is sitting on a flat, stable surface. Do not perform testing with the analyzer held in the hand. " After inserting the test strip(s), do not move the analyzer unt |
| Quantity | 67643 total |
| Distribution | Domestic distribution nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023558 | PTS PANELS LIPID PANEL TEST STRIPS Polymer Technology Systems, Inc., Nov 15, 2002 |