Drug recall
CHOL+HDL+GLU test strips, REF 2412
FDA recall event 82331 · Class II · Polymer Technology Systems, Inc.
Key facts
| Event ID | 82331 |
|---|---|
| Recall numbers | Z-1371-2019, Z-1372-2019, Z-1373-2019 |
| Recalling firm | Polymer Technology Systems, Inc. |
| Product type | Devices |
| Products | CHOL+HDL+GLU test strips, REF 2412, Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412, Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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…, 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 displayed, Some lots of test strips do not fit… |
| Initiation date | Jan 16, 2019 |
| Report date | May 29, 2019 |
| Termination date | Jun 24, 2020 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 3002698769 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: