Z-0245-2007

VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge...

Name: Z-0245-2007 VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge...
Creator: Ortho-Clinical Diagnostics
Published: 2006-10-09
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2006-10-09 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of 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)... on 2006-10-09. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0245-2007
Status: Terminated
Initiated: 2006-10-09
Posted: 2006-12-05
Terminated: 2008-05-22
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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
Product code: CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Reason for recall: 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 tag: manufacturing process
FDA 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-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.
Quantity in commerce: Cat./REF # 166 8409: Domestic - 3031, Foreign - 2511; Cat./ REF # 829 7749: Domestic - 1682, Foreign - 3553
Distribution: Worldwide distribution
Product codes and lots: Catalog/REF Nos. 166 8409 and 829 7749. All lots.

Product code CHI

K845027Class IKodak Ektachem Clinical Chemistry SlidesEastman Kodak Company / cleared 1985-01-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)