Recall Z-2460-2026
- Recall number
- Z-2460-2026
- Event number
- 98979
- Firm
- Accriva Diagnostics, Inc.
- Firm FEI
- 2250033
- Product code
- GGN
- Status
- Open, Classified
- Initiated
- 2026-04-30
- Posted
- 2026-06-16
- Root cause
- Process control
- 510(k) numbers
- K202101, K000679, K952622, K902363, K100716, K960234, K981248, K994159, K955278, K961189, K091284, K010750, K021022, K992829, K941860, K142132, K090563, K163498, K010324, K921344, K042333, K161316, K133582, K980982, K991439, K093848, K062840, K880302, K051472, K971219
Product#
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Reason for Recall#
Assayed Whole blood control contains labeling with incorrect performance range.