Recall Z-1070-2018— Stanbio Laboratory, LP
Class II · Terminated
Class II FDA medical device recall by Stanbio Laboratory, LP, initiated 2018-02-13, terminated 2018-09-27. It names one FDA 510(k) clearance: K974370. Product: 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.. Reason: All patient serum samples yield a weakly positive test result..
- Recalling firm
- Stanbio Laboratory, LP
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-13
- Terminated
- 2018-09-27
- Firm location
- Boerne, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
All patient serum samples yield a weakly positive test result.
Data sourced from openFDA. This site is unofficial and independent of the FDA.