SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT

FDA device recall Z-1448-2015 · posted 2015-04-15 · Terminated

Recall details

Recalling firm

Vitrolife Inc

Reason for recall

The firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new formulation causing the motility of sperm cells to reduce in certain samples when the new bead solution was added.

Action taken

FertiPro sent an Urgent: Medical Device Recall letter dated December 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to check if they have stock of the concerned lots and provide a confirmation that they have destroyed the affected products. Distributors were asked to inform their customers and instruct them to do the same. For further questions you may call (858) 824-0888.

Root cause

Component design/selection

Status

Terminated

Product code

KTO

Quantity affected

45 kits

Distribution

US Distribution to the state of : OR., and Internationally to Argentina.

Date initiated

2014-12-22

Date posted

2015-04-15

Date terminated

2015-05-05

Location

San Diego, CA