Z-2598-2018Class III

BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx...

Name: Z-2598-2018 BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx...
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2018-05-16
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2018-05-16 / Terminated / root cause: manufacturing process

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton... on 2018-05-16. FDA classified it as Class III and gives the reason as "The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2598-2018
Classification: Class III
Status: Terminated
Initiated: 2018-05-16
Posted: 2018-07-13
Terminated: 2018-08-13
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and 40-tube racks. A barcode reader verifies the ID on tube racks and individual tubes in 30- tube racks. A built-in imaging system provides safety checks, such as verifying the correct rack type and tube layout, and ensures the tubes were loaded correctly.
Product code: OYE Flow Cytometric Reagents And Accessories.
Reason for recall: The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, BD Life Sciences, produced the "URGENT PRODUCT RECALL-CORRECTION" letter dated 4/6/2018 to its customers during an on-site visit. by the field service engineer made beginning 5/16/2018 to correct the issue. The visits were completed 6/15/2018. If you require further assistance, contact BD Customer/Technical Support BD Customer Support at 877.232.8995 (prompt 2) for instruments in the United States. For customers outside the US, contact your local BD representative or distributor.
Quantity in commerce: 8 devices
Distribution: US Distribution was made to FL, KS, KY, MA, NJ, and SD.
Product codes and lots: Serial #2662879000001, UDI (01)00382906628794(11)170915(21)Z662879000001; Serial #2662879000002, UDI (01)00382906628794(11)170915(21)Z662879000002; Serial #2662879000003, UDI (01)00382906628794(11)170915(21)Z662879000003; Serial #2662879000004, UDI (01)00382906628794(11)170915(21)Z662879000004; Serial #2662879000009, UDI (01)00382906628794(11)170915(21)Z662879000009; Serial #2662879000010; UDI (01)00382906628794(11 )170915(21)Z662879000010; Serial #2662879000011; UDI (01)00382906628794(11)170915(21)Z662879000011; and Serial #2662879000012, UDI (01)00382906628794(11)170915(21)Z662879000012.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2598-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2598-2018	Class III	Terminated	Voluntary: Firm initiated	2018-08-08	2018-08-02

Product code OYE

K170974Class IIBD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNKBecton, Dickinson and Company / cleared 2017-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)