Recall Z-0245-2007 ยท CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Ortho-Clinical Diagnostics
VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS Chemistry Systems typically used in hospital laboratories. Ortho-Clinical D
| Date | Dec 5, 2006 (initiated Oct 9, 2006) |
| Status | Terminated |
| Reason | The firm identified circumstances in which biased results or calibration failures can be observed when using any lot of VITROS LIPA slides if they have been stored on the VITROS Chemistry Systems for more than 2 days. |
| Root cause | Other |
| Action | On 10/09/06, Ortho-Clinical Diagnostics sent "IMPORTANT DISTRIBUTOR NOTIFICATION" Letters and "Confirmation of Receipt" Forms via Federal Express to all distributor accounts informing them of the "field correction", and instructing them to inform their customers who received these slides of this issue. OCD foreign affiliates were informed of this action by e-mail on 10/09/06, and instructed them to inform their customers who received the LIPA slides of this "field correction". OCD also sent "IMPORTANT PRODUCT CORRECTION NOTIFICATION" Letters and "Confirmation of Receipt" Forms to US end-use |
| Quantity | Cat./REF # 166 8409: Domestic - 3031, Foreign - 2511; Cat./ REF # 829 7749: Domestic - 1682, Foreign - 3553 |
| Distribution | Worldwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K845027 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES Eastman Kodak Company, Jan 18, 1985 |