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Open, Classified

OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004

FDA Recall Z-2310-2021 · Posted None

Recalling FirmOPTI Medical Systems, Inc
Recall StatusOpen, Classified
Product CodeQJR
Date Initiated2021-06-25
Product Quantity3552 kits

Reason for Recall

The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix.

Firm Action

/The firm disseminated a technical bulletin beginning on 06/25/2021 by email identifying the /problem and providing additional instructions to be implemented when using the product.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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