FDA Device recall Z-1652-2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Descri…
- FDA Device
- Class II
- ongoing
- Published 2025-04-30
On 2025-04-30 the FDA classified a Class II recall of Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Descri… by Abbott Laboratories, citing when expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1652-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-18 |
| Published | 2025-04-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Reason
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Identifiers
| code_info | UDI-DI 00380740017170 SNs: 30039BG 34021BG 34079BG 34108BG 34123BG 34138BG 34140BG 34149BG 34152BG 34161BG 34177BG 341…UDI-DI 00380740017170 SNs: 30039BG 34021BG 34079BG 34108BG 34123BG 34138BG 34140BG 34149BG 34152BG 34161BG 34177BG 34186BG 34232BG 34242BG 34272BG 34288BG 34302BG 34323BG 34339BG 34349BG 34353BG 34354BG 34364BG 34372BG 34391BG 34395BG 34414BG 34433BG 34439BG 34448BG 34451BG 34458BG 34466BG 34468BG 34473BG 34478BG 34488BG 34491BG 34531BG 34533BG 34539BG 34551BG 34555BG 34559BG 34565BG 34566BG 34598BG 34604BG 34605BG 34620BG 34633BG 34634BG 34646BG 34667BG 34669BG 34695BG 34726BG 34734BG 34736BG 34742BG 34744BG 34758BG 34768BG 34788BG 34789BG 34791BG 34793BG 34805BG 34816BG 34837BG 34839BG 34841BG 34844BG 34850BG 34868BG 34878BG 34881BG 34884BG 34888BG 34893BG 34902BG 34903BG 34907BG 34918BG 34927BG 34933BG 34940BG 34942BG 34950BG 34953BG 34957BG 34965BG 34971BG 34974BG 34975BG 34976BG 34980BG 34984BG 34988BG 34997BG 35016BG 35029BG 35045BG 35049BG 35050BG 35056BG 35061BG 35062BG 35066BG 35067BG 35073BG 35077BG 35089BG 35097BG 35102BG 35104BG 35105BG 35111BG 35112BG 35117BG 35127BG 3512 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1652-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.