GTQClass I

Antistreptolysin - Titer/streptolysin O Reagent

Microbiology · 21 CFR 866.3720

MDR events5All time

Recalls4All time

Registered firms45Currently listed

510(k) clearances37All time

Recent MDR events

5 adverse event reports on file

Event type breakdown

Malfunction5

Most-reported manufacturers

Roche Diagnostics4 Beckman Coulter, Inc.1

Recalls

4 recall events for this product code

Remel, Inc
TerminatedMay 19, 2009
Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201 (450 tests), rapid latex agglutination test for the identification of St
These lots may exhibit false positive reactions with strains of Staphylococcus epidermidis that may result in the mis-identification of Staphylococcus aureus.
Z-1400-2009 · View FDA record ↗
BD Diagnostic Systems / Lee Laboratories
TerminatedSep 11, 2008
DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic.
Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism.
Z-1319-2008 · View FDA record ↗
Roche Diagnostics Corp.
TerminatedAug 9, 2006
Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216) Lot No. 674653
The vial containing the R2 reagent is labeled as R1 reagent and if placed in the R1 slot of the analyzer, erroneous results will be obtained. (extremely low patient and control results)
Z-1385-06 · View FDA record ↗
Beckman Coulter Inc
TerminatedJul 23, 2004
Array Systems Calibrator 5
The ASO (MPE) assayed in Buffer cannot be programmed or calibrated using Array Calculator 5.
Z-1152-04 · View FDA record ↗

Registered firms

45 firms currently registered for this product code

510(k) clearances

37 clearances for this product code