FDAClass IIJuly 1, 2015

VersaTREK Instrument Series 240 recall

VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms…

Why was VersaTREK Instrument Series 240 recalled?

Use of the recalled product may result in false positive reports.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial numbers: 0169039201140624, 0169040501140626, 0169050101141007, 0169068601141216, 0169078101150213, 2163X1013, 2164X1013, 2165X1013, 2166X1013, 2167X1013, 2168X1013, 2169X1013, 2170X1013, 2171X1013, 2172X1013, 2173X1013, 2174X1013, 2175X1013, 2176X1013, 2177X1013, 2178X1013, 2179X1013, 2180X1013, 2181X1013, 2182X1013, 2183X1013, 2184X1013, 2185X1013, 2186X1013, 2187X1013, 2188X1013, 2189X1013, 2190X1013, 2191X1013, 2192X1113, 2193X1113, 2194X1113, 2195X1113, 2196X1113, 2199X1113, 2201X1113, 2202X1113, 2203X1113, 2204X1113, 2205X1113, 2206X1113, 2207X1113, 2208X1113, 2209X1113, 2210X1113, 2211X1113, 2212X1113, 2213X1113, 2214X1113, 2216X1113, 2217X1113, 2218X1213, 2219X1213, 2220X1213, 2221X1213, 2222X1213, 2223X1213, 2224X1213, 2225X1213, 2226X1213, 2227X1213, 2228X1213, 2229X1213, 2230X1213, 2231X1213, 2232X1213, 2233X1213, 2234X1213, 2235X1213, 2237X1213, 2238X1213, 2239X1213, 2240X1213, 2241X1213, 2242X1213, 2243X1213, 2245X1213, 2249X0114, 2250X0114, 2251X0114, 2252X0114, 2253X0114, 2254X0114, 2255X0114, 2256X0114, 2257X0114, 2261X0114, 2262X0114, 2263X0114, 2264X0114, 2268X0114, 2269X0114, 2276X0214, 2277X0214, 2278X0214, 2279X0214, 2280X0214, 2281X0214, 2282X0214, 2286X0214, 2287X0214, 2288X0214, 2289X0214, 2290X0214, 2306X0714, 2307X0714, 2309X0714, 2311X0714, 2312X0714, 2314X0714, 2315X0714, 2316X0714, 2317X0714, 2318X0714, 2320X0714, 2321X0814, 2322X0814, 2323X0814, 2330X0814, 2332X0814, 2333X0814, 2334X0814, 2336X0814, 2337X0814, 2338X0814, 2339X0814, 2340X0814, 2342X0814, 2345X0914, 2346X0914, 2347X0914, 2348X0914, 2349X0914, 2352X0914, 2353X0914, 2359X0914, 2365X0914, and 2366X0914;

Product
VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms…
Recalling firm
Remel Inc
Quantity
143 devices
Distribution
Worldwide distribution: US (nationwide) to states of AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA and the countries of Canada, People's Republic of China, Egypt, Finland, France, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam.
Recall date
July 1, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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