GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.
WALLAC OY
The hazard
Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model (01)06438147321704(17)260531(10)764085 (1076408501)Model (01)06438147321704(17)260531(10)765033 (1076503301)Model (01)06438147321704(17)260731(10)765231 (1076523101)Model (01)06438147321704(17)260731(10)765316 (1076531601)Model (01)06438147321704(17)261031(10)766420 (1076642001)Model (01)06438147321704(17)261031(10)766894 (1076689401)Model (01)06438147321704(17)261130(10)767873 (1076763801)Model (01)06438147321704(17)261130(10)768361 (1076836101)Model (01)06438147321704(17)261130(10)768703 (1076870301)Model (01)06438147321704(17)270228(10)769355 (1076935501)Model (01)06438147321704(17)270228(10)769542 (1076954201)Model (01)06438147321704(17)270228(10)769632 (1076963201)Model (01)06438147321704(17)270228(10)769671 (1076967101)Model (01)06438147321704(17)270228(10)769782 (1076978201)Model (01)06438147321704(17)270228(10)769871 (1076987101)Model (01)06438147321704(17)270228(10)769975 (1076997501)Model (01)06438147321704(17)270228(10)770078 (1077007801)Model (01)06438147321704(17)270228(10)770086 (1077008601)Model (01)06438147311347(17)260531(10)763396 (1076339602)Model (01)06438147311347(17)260531(10)764209 (1076420901)Model (01)06438147311347(17)260531(10)764209 (1076420902)Model (01)06438147311347(17)260731(10)765317 (1076531702)Model (01)06438147311347(17)260731(10)7653177 (1076531703)Model (01)06438147311347(17)261031(10)766378 (1076637801)Model (01)06438147311347(17)261031(10)766943 (1076694301)UPC 06438147321704UPC 06438147311347Would you have heard about this one?
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