notyard
04-14-2009, 12:01 PM
FDA class II recall:
PRODUCT
a) Mainline Confirms Strep A, 1) Catalog # 3030-20 and 2) Catalog # 3030-40, Recall # Z-0525-2009;
b) Mainline Confirms Strep A DOTS, Catalog # 4040, Recall # Z-0526-2009;
c) Mainline Confirms III Serum/Urine control set, Catalog # 3029-CTR, Recall # Z-0527-2009;
d) Mainline hCG Accuracy Check, Catalog # 3c1001, Recall # Z-0528-2009;
e) Mainline Confirms hCG Serum/Urine III, Catalog # 3029-25, Recall # Z-0529-2009;
f) f.y.i. hCG Urine one-step pregnancy test, Catalog # 43065, Recall # Z-0530-2009
g) Mainline Confirms hCG urine pregnancy test, Catalog # 6008C, Recall # Z-0531-2009
CODE
a) 1) Lots: 94355, 94385, 94395, 94415, 94445, 94455, 94485, 94505, 94545, 94585, and 94595; 2) Lots 94350, 94370, 94380, 94410, 94420, 94440, 94450, 94480, 94500, 94510, 94540, 94580, 94590, 94610, 94620, 94630, and 94880;
b) Lots: 92465, 92480, 92525, 92540, 92580, 92600, 92640, 92650, 92680, 92700, 92705, 92720, and 92721;
c) Lot: 06054;
d) Lots: 50074 and 50075;
e) Lots: 96101- 96206, 96218, 96235, 96260, 96295, 96300, 96320, 96360, 96380, and 96381;
f) Lot: 20087;
g) Lots: 19540, 19590, 19914, 20110, 20343, 20537, 20717, 20906, 21060, 21089, 21495, 21733, 21762, 22407, 22408, 22926, 23217, 23525, 23694, 23703, 23994, 24483, and 25080
RECALLING FIRM/MANUFACTURER
Mainline Technology, Inc., Ann Arbor, MI, by letter dated August 18, 2008. Firm initiated recall is ongoing.
REASON
Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.
VOLUME OF PRODUCT IN COMMERCE
45,330 kits
DISTRIBUTION
Nationwide, Belgium and Switzerland
PRODUCT
a) Mainline Confirms Strep A, 1) Catalog # 3030-20 and 2) Catalog # 3030-40, Recall # Z-0525-2009;
b) Mainline Confirms Strep A DOTS, Catalog # 4040, Recall # Z-0526-2009;
c) Mainline Confirms III Serum/Urine control set, Catalog # 3029-CTR, Recall # Z-0527-2009;
d) Mainline hCG Accuracy Check, Catalog # 3c1001, Recall # Z-0528-2009;
e) Mainline Confirms hCG Serum/Urine III, Catalog # 3029-25, Recall # Z-0529-2009;
f) f.y.i. hCG Urine one-step pregnancy test, Catalog # 43065, Recall # Z-0530-2009
g) Mainline Confirms hCG urine pregnancy test, Catalog # 6008C, Recall # Z-0531-2009
CODE
a) 1) Lots: 94355, 94385, 94395, 94415, 94445, 94455, 94485, 94505, 94545, 94585, and 94595; 2) Lots 94350, 94370, 94380, 94410, 94420, 94440, 94450, 94480, 94500, 94510, 94540, 94580, 94590, 94610, 94620, 94630, and 94880;
b) Lots: 92465, 92480, 92525, 92540, 92580, 92600, 92640, 92650, 92680, 92700, 92705, 92720, and 92721;
c) Lot: 06054;
d) Lots: 50074 and 50075;
e) Lots: 96101- 96206, 96218, 96235, 96260, 96295, 96300, 96320, 96360, 96380, and 96381;
f) Lot: 20087;
g) Lots: 19540, 19590, 19914, 20110, 20343, 20537, 20717, 20906, 21060, 21089, 21495, 21733, 21762, 22407, 22408, 22926, 23217, 23525, 23694, 23703, 23994, 24483, and 25080
RECALLING FIRM/MANUFACTURER
Mainline Technology, Inc., Ann Arbor, MI, by letter dated August 18, 2008. Firm initiated recall is ongoing.
REASON
Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.
VOLUME OF PRODUCT IN COMMERCE
45,330 kits
DISTRIBUTION
Nationwide, Belgium and Switzerland