FDA Medical Device Recalls (openFDA)
Nerl Diagnostics LLC: S/P Orange 50g Glucose Tolerance Beverage, 10 oz glass bottles, 12 bottles/case, labeled in part ***Cardinal Health McGaw Park, IL 60085-6787 USA*** For prescription use only. Product is used in support of diagnostics testing for hyperglycemia and hypoglycemia.
- Recall number
- Z-0278-2009
- Recalling firm
- Nerl Diagnostics LLC
- Product
- S/P Orange 50g Glucose Tolerance Beverage, 10 oz glass bottles, 12 bottles/case, labeled in part ***Cardinal Health McGaw Park, IL 60085-6787 USA*** For prescription use only. Product is used in support of diagnostics testing for hyperglycemia and hypoglycemia.
- Status
- Terminated
- Initiated
- 2008-04-23
- Posted
- 2008-11-04
- Terminated
- 2012-11-26
- Reason
- Beverage may contain glass particles.
- Root cause
- Other
- Action
- The recalling firm notified distribution centers by letter dated 04/23/08 and advised of a single report of glass found in a bottle. The notifications further advised distributors to quarantine referenced product, notify their customers and return the enclosed reply form. Distributors were requested to return or destroy product for replacement. Please contact NERL Diagnostics, LLC at 1-401-824-2046 for assistance.
- Quantity
- 25908 bottles
- Distribution
- Nationwide.
- Lot, serial or model codes
- lot 4067, Exp 12-2009
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MRV
- Firm FEI
- 3002879536
- Firm city
- Baltimore
- Firm state
- MD
- 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