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Terminated

RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.

FDA Recall Z-1070-2018 · Posted None

Recalling FirmStanbio Laboratory, LP
Recall StatusTerminated
Product CodeDHR
Date Initiated2018-02-13
Date Terminated2018-09-27
Product Quantity686 units

Reason for Recall

All patient serum samples yield a weakly positive test result.

Firm Action

Recall notification letters were sent to affected consignees on 2/14/2018. The letter identified the affected product, problem and actions to be taken. The letter instructed the consignee to stop using affected products, quarantine products, and exchange the kit for an unaffected one.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974370RAPET RFStanbio Laboratory · 1998-02-17

Official Source

View FDA Recall →

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

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