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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS Chemistry Products LIPA Slides GEN 48 Coating 3235

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 Class 3 Device Recall VITROS Chemistry Products LIPA Slides GEN 48 Coating 3235see related information
Date Initiated by FirmOctober 09, 2006
Date PostedDecember 05, 2006
Recall Status1 Terminated 3 on May 22, 2008
Recall NumberZ-0245-2007
Recall Event ID 36512
510(K)NumberK845027 
Product Classification LIPA in vitro diagnostic - Product Code CHI
ProductVITROS 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
Code Information Catalog/REF Nos. 166 8409 and 829 7749. All lots.
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester NY 14626
For Additional Information ContactMr. Joseph Falvo
585-453-5735
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionOn 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 CommerceCat./REF # 166 8409: Domestic - 3031, Foreign - 2511; Cat./ REF # 829 7749: Domestic - 1682, Foreign - 3553
DistributionWorldwide distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CHI
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