Cobas¿ 8000 modular analyzer series software version recall
Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated…
Why was Cobas¿ 8000 modular analyzer series software version recalled?
When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain assays instead of Diluent Universal. This may cause incorrect results under specific circumstances if all of the following conditions are met simultaneously: More than a total of 2000 reagent kits or diluents have been registered on the cobas e 602 modules within one system core, and two different diluent
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number 05990378001 Serial Numbers 1017-06, 1021-03, 1021-05, 1142-09, 1145-10, 1140-01, 1125-07, 1128-02, 1146-01, 1146-02, 1146-03, 1171-10, 1169-06, 1169-08, 1169-09, 1172-09, 1156-01, 1156-02, 1156-09, 1160-04, 1160-06, 1016-05, 1017-01, 1139-08, 1139-10, 1140-07, 1140-08, 1140-10, 1156-06, 1156-07, 1158-09, 1160-01, 1160-05, 1173-01, 1139-06, 1139-07, 2374-11, 1127-08, 1138-08, 1138-10, 1139-01, 1156-08, 1156-10, 1173-10, 1156-05, 1158-10, 1139-09, 1131-08, 1132-01, 1132-02, 1171-07, 1171-08, 1171-09, 1147-05, 1149-01, 1124-05, 1124-06, 1132-03, 1132-04, 1147-05, 1149-01, 1128-05, 1128-06, 1139-02, 1139-03, 1139-04, 1139-05, 1146-05, 1146-06, 1147-04, 1156-04, 1132-05, 1132-10, 1137-02, 1147-05, 1149-01, 1128-05, 1128-06, 1149-07, 1149-08, and 1167-02.
- Product
- Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated…
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 72 units
- Distribution
- USA Nationwide Distribution
- Recall date
- May 29, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)