Lower riskMedical device recall · FDA · Published October 14, 2019
Ortho Clinical Diagnostics Urine Electrolyte Diluent Recall: Stability Risk After 7 Days
Ortho Clinical Diagnostics recalls Urine Electrolyte Diluent (Product Code 1112352) due to potential instability when stored in 2mL cups for 7 days. Affected lots have expiry dates from Feb 2020 to Aug 2021.
Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days.
“Ortho Clinical Diagnostics Urine Electrolyte Diluent Recall: Stability Risk After 7 Days.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66793-ortho-clinical-diagnostics-urine-electrolyte-diluent-recall-stability-risk-after. Based on FDA recall #Z-0740-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0740-2020%22&limit=1).
The FDA announced on 2019-10-14 that Ortho Clinical Diagnostics Inc. is recalling Urine Electrolyte Diluent due to potential instability when stored for seven days in a 2mL cup, according to the FDA.
Lot codes with expiry dates: V6391 (2020-02-26), W6895 (2020-09-20), X7127 (2021-01-17), Y7593 (2021-08-28)
Quantity: 2,573 units
Distribution: US Nationwide and countries BM, AU, BR, CA, CL, CN, CO, IN, JP, MX, SG, GB, FR, DE, IT, ES, PT, PL, RU, DK, NO, SE, BE, NL
The hazard
The recall addresses the potential instability of VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days, according to the FDA.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since 2017-07-10. Other recent recalls of similar products include Beckman Coulter DxH Diluent Recall (2025-11-10), Fresenius Medical Care Bicarby Dialysate Recall (2026-05-07), and Bioporto ProNephro AKI Reagent Kit Recall (2026-05-18).
How to tell if you have this one
Check for Product Code 1112352 with expiry dates: V6391 (Feb 2020), W6895 (Sep 2020), X7127 (Jan 2021), or Y7593 (Aug 2021). The product is used to dilute urine specimens for sodium and potassium analysis on specific lab systems.
Brand
Ortho Clinical Diagnostics
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution and countries BM, AU, BR, CA, CL, CN, CO, IN, JP, MX, SG, GB, FR, DE, IT, ES, PT, PL, RU, DK, NO, SE, BE, NL.
Recall number
Product, codes & lots
Quantity
Z-0739-2020
7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.; Lot with Expiry Date: D6289 2019-11-20 E6382 2020-01-15 F6602 2020-05-02 G6679 2020-08-13 H6897 2020-10-01 J7129 2021-01-23 K7421 2021-07-01 L7592 2021-08-26
16,584
Z-0740-2020
Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.; Lot with Expiry Date: V6391 2020-02-26 W6895 2020-09-20 X7127 2021-01-17 Y7593 2021-08-28
2,573
Based on the official FDA remedy
What to do — step by step
Check Product Expiry
Verify the product code and expiry date on the container to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and countries BM, AU, BR, CA, CL, CN, CO, IN, JP, MX, SG, GB, FR, DE, IT, ES, PT, PL, RU, DK, NO, SE, BE, NL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0740-2020 (October 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0740-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.