FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROS Chemistry Products GLU DT Slides quantitatively measure glucose (GLU) concentration in serum and plasma. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. .
- Recall number
- Z-0151-2007
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROS Chemistry Products GLU DT Slides quantitatively measure glucose (GLU) concentration in serum and plasma. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. .
- Status
- Terminated
- Initiated
- 2006-09-27
- Posted
- 2006-11-04
- Terminated
- 2012-08-03
- Reason
- Positively biased results when using the VITROS Chemistry Products GLU DT Slides GEN 56.
- Root cause
- Other
- Action
- On 9/26/06, the recalling firm notified its foreign affiliate consignees of this 'field correction', and instructed them to inform their customers who received these slides of this issue, provided them with an updated Calibration Data Module and instructed to re-calibrate these slides for continued use. On 9/27/06, all US end-use consignees were informed of this issue via Federal Express overnight letter (dated 9/27/06), and instructing them to re-calibrate these slides for continued use after they have installed the Calibration Data Module. The new CDMs were sent to all customers with VITROS DT 60/DT60 II Chemistry systems starting 9/27/06 concurrent with, but separate, from the correction letters. This includes consignees who purchased their GLU DT slides from distributors. On 9/28/06, all distributors were notified of this 'field correction', providing instructions and 'Questions & Answers' for them, and instructing them to inform their customers who received these slides of this issue. Calibration Data Modules were sent to all customers with VITROS DT 60/DT60 II Chemistry Systems.
- Quantity
- 93,252 boxes (25 slides per box) in total
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- REF 153 2316
- 510(k) numbers
- ["K841503"]
- PMA numbers
- not on file
- Product code
- CGA
- Firm FEI
- 1000136573
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28