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U.S. Department of Health and Human Services

Class 2 Device Recall SpermMar Test

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  Class 2 Device Recall SpermMar Test see related information
Date Initiated by Firm December 22, 2014
Date Posted April 15, 2015
Recall Status1 Terminated 3 on May 05, 2015
Recall Number Z-1448-2015
Recall Event ID 70131
Product Classification Reagent, immunoassay, igg - Product Code KTO
Product SpermMar Test
0.7ml Beads Particles

Label on bottle:
SpermMar Test IgA
0.7ml Beads/Particles-50 Tests
IND REF SPMA_S
LOT Expiration
DO NOT FREEZE/NE PAS CONGELER
FertiPro N.V.

Label on box:
SpermMar
Test
IGA
50 Determination
Test Kit
CONTENTS
1 vial SpermMar Latex Particles 0.7 ml
REF SPMA_S
FertiPro
FertiPro N.V.

Label on box:
SpermMar
Test
IgA
50 Determination Test Kit
Contents: 1 vial SpermMar latex particles, 0.7ml
FertiPro N.V.
For In Vitro Diagnostic
Use


SpermMar IqA Test
Manufacturer's Product Number/Catalog Number: SPMA_S

Lot/Serial Number Expiration Date
FP14A09 02/29/2016
FP14A10 04/30/2016
FP14A11 04/30/2016

Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.
Code Information Manufacturer's Product Number/Catalog Number: SPMA_S  Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016
Recalling Firm/
Manufacturer		 Vitrolife Inc
6835 Flanders Dr Ste 500
San Diego CA 92121-3927
For Additional Information Contact
858-824-0888
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
Action 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.
Quantity in Commerce 45 kits
Distribution US Distribution to the state of : OR., and Internationally to Argentina.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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