Stanbio Laboratory, LP: Medical Device Recall in 2018 - (Recall #: Z-1070-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 13, 2018

Date Posted: March 21, 2018

Recall Number: Z-1070-2018

Event ID: 79245

Reason for Recall:

All patient serum samples yield a weakly positive test result.

Status: Terminated

Product Quantity: 686 units

Code Information:

Lot 21675

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated