—#48782

Product

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 Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08

FDA product code: CHI — Lipase-Esterase, Enzymatic, Photometric, Lipase
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K845027
Affected lot / code info: Catalog/REF Nos. 166 8409 and 829 7749. All lots.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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-user consignees that received the LIPA slides directly from OCD via US Postal Service, informing them of this "field correction" and that they may continue to use their current lot of Coating 3235 LIPA Slides until replacement product arrived providing that they followed the instructions in the letter.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Drive, Rochester, New York 14626

Distribution

Distribution pattern: Worldwide distribution

Timeline

Recall initiated: 2006-10-09
Posted by FDA: 2006-12-05
Terminated: 2008-05-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48782. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.