Z-1070-2018Class II

RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry...

Name: Z-1070-2018 RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry...
Creator: Stanbio Laboratory, LP
Published: 2018-02-13
License: https://open.fda.gov/license/

Stanbio Laboratory / initiated 2018-02-13 / Terminated / root cause: design

FDA source

Stanbio Laboratory, LP began a recall of 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... on 2018-02-13. FDA classified it as Class II and gives the reason as "All patient serum samples yield a weakly positive test result". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1070-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-13
Posted: 2018-03-15
Terminated: 2018-09-27
Recalling firm: Stanbio Laboratory
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.
Product code: DHR System, Test, Rheumatoid Factor
Reason for recall: All patient serum samples yield a weakly positive test result.
Root cause tag: design
FDA root cause: Component design/selection
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.
Quantity in commerce: 686 units
Distribution: Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad
Product codes and lots: Lot 21675

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1070-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1070-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-15

Product code DHR

K974370Class IIRapet RFStanbio Laboratory / cleared 1998-02-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)