Home › Device types › GKA
Abnormal Hemoglobin Quantitation
FDA product code GKA · Class 2 · Hematology
42
Registered devices
2
Adverse events
10
Recalls
23
510(k) clearances
Devices with this code
Trinity Biotech — PRIMUS CORPORATIONTrinity Biotech — PRIMUS CORPORATIONTrinity Biotech — PRIMUS CORPORATIONRESOLVE Systems Neonatal Hemoglobin Kit — Wallac OyTrinity Biotech — PRIMUS CORPORATIONVARIANT nbs Newborn Screening — BIO-RAD LABORATORIES, INC.Trinity Biotech — PRIMUS CORPORATIONRESOLVE Systems JB-2 Staining System — Wallac OyVARIANT nbs — BIO-RAD LABORATORIES, INC.RESOLVE Systems Hb Elution Solution — Wallac OyTrinity Biotech — PRIMUS CORPORATIONRESOLVE Systems Neonatal Hemoglobin Kit — Wallac OyTrinity Biotech — PRIMUS CORPORATIONCAPI 3 NEONAT HEMOLYSING SOLUTION — SEBIAVARIANT nbs — BIO-RAD LABORATORIES, INC.MINICAP HEMOGLOBIN — SEBIAVARIANT nbs — BIO-RAD LABORATORIES, INC.RESOLVE Systems Hb Elution Solution — Wallac OyHemoglobin Variants System — BIO-RAD LABORATORIES, INC.Trinity Biotech — PRIMUS CORPORATIONVARIANT nbs — BIO-RAD LABORATORIES, INC.RESOLVE Systems Hemoglobin Kit — Wallac OyHemoglobin Variants System — BIO-RAD LABORATORIES, INC.Hemoglobin Variants System — BIO-RAD LABORATORIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-04-07 | Bio-Rad Laboratories, Inc. | The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam |
| 2020-10-09 | Primus Corporation | The product did not receive pre-market approval or clearance. |
| 2018-11-01 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | lack of 510K |
| 2018-11-01 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | lack of 510K |
| 2018-11-01 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | lack of 510K |
| 2018-11-01 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | lack of 510K |
| 2018-11-01 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | lack of 510K |
| 2010-04-22 | Bio-Rad Laboratories Inc | The presence of parameters for Version 40400-S on the labeled VARIANT Sickle Cell Short ROM Card instead of Version 80300-S. |
| 2010-04-14 | Bio-Rad Laboratories Inc | The affected resin Update CD-ROMs cause all user-defined settings in the Setup/Test/Data Setup sub screen and Set/Test/Pattern Setting sub screen to be overwrit |
| 2004-09-14 | PerkinElmer LAS Inc | The product insert for the test kits is incorrect with regard to the acceptable storage temperature for the Agarose IEF gel component. The kit and IEF gel labe |
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