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U.S. Department of Health and Human Services

Class 2 Device Recall FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2)

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  Class 2 Device Recall FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) see related information
Date Initiated by Firm September 10, 2021
Create Date October 12, 2021
Recall Status1 Open3, Classified
Recall Number Z-0087-2022
Recall Event ID 88700
510(K)Number K121012  
Product Classification Electrode, ion specific, potassium - Product Code CEM
Product FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Code Information Impacted Module: ADVIA Centaur XP/XPT Interface Module, Part No. FLX-021-00; FLX-021-10; APT-021-00  Serial numbers: ***FLEXLAB*** FLX.0109 FLX.0127 FLX.0128 FLX.0129 FLX.0132 FLX.0133 FLX.0139 FLX.0146 FLX.0147 FLX.0149 FLX.0151 FLX.0153 FLX.0154 FLX.0156 FLX.0157 FLX.0159 FLX.0160 FLX.0162 FLX.0165 FLX.0166 FLX.0167 FLX.0169 FLX.0170 FLX.0172 FLX.0173 FLX.0174 FLX.0179 FLX.0180 FLX.0182 FLX.0191 FLX.0192 FLX.0193 FLX.0194 FLX.043 FLX.069 FLX.085 FLX.086 FLX.087 FLX.093 FLX.097  ***ACCELERATOR a3600*** ACP.334   ***APTIO AUTOMATION*** AP2.0002 AP2.0003 AP2.0004 AP2.0005 AP2.0006 AP2.0007 AP2.0008 AP2.009 AP2.0010 AP2.0011 AP2.0012 AP2.0014 AP2.0015 AP2.0016 AP2.0017 AP2.0018 AP2.0019 AP2.0022 AP2.0023 AP2.0024 AP2.0025 AP2.0026 AP2.0027 AP2.0028 AP2.0029 AP2.0031 AP2.0032 AP2.0033 AP2.0035 AP2.0037 AP2.0038 AP2.0039 AP2.0040 AP2.0041 AP2.0043 AP2.0045 AP2.0046 AP2.0047 AP2.0048 AP2.0049 AP2.0050 AP2.0051 AP2.0052 AP2.0053 AP2.0054 AP2.0055 AP2.0057 AP2.0058 AP2.0059 AP2.0061 AP2.0062 AP2.0063 AP2.0064 AP2.0065 AP2.0066 AP2.0067 AP2.0070 AP2.0075 AP2.0076 AP2.0077 AP2.0078 AP2.0079 AP2.0080 AP2.0081 AP2.0082 AP2.0083 AP2.0084 AP2.0085 AP2.0087 AP2.0088 AP2.0089 AP2.0090 AP2.0091 AP2.0092 AP2.0093 AP2.0094 AP2.0095 AP2.0097 AP2.0098 AP2.0100 AP2.0102 AP2.0103 AP2.0104 AP2.0105 AP2.0106 AP2.0107 AP2.0108 AP2.0109 AP2.0110 AP2.0111 AP2.0112 AP2.0115 AP2.0117 AP2.0118 AP2.0119 AP2.0122 AP2.0123 AP2.0124 AP2.0126 AP2.0127 AP2.0128 AP2.0129 AP2.0131 AP2.0132 AP2.0133 AP2.0135 AP2.0136 AP2.0137 AP2.0138 AP2.0141 AP2.0142 AP2.0144 AP2.0145 AP2.0147 AP2.0149 AP2.0150 AP2.0153 AP2.0155 AP2.0156 AP2.0160 AP2.0161 AP2.0162 AP2.0165 AP2.0166 AP2.0168 AP2.0173 AP2.0178 AP2.0179 AP2.0180 AP2.0182 AP2.0186 AP2.0190 AP2.0191 AP2.0192 AP2.0193 AP2.0195 AP2.0198 AP2.0199 AP2.0200 AP2.0204 AP2.0205 AP2.0206 AP2.0207 AP2.0208 AP2.0212 AP2.0216 AP2.0219 AP2.0221 AP2.0222 AP2.0223 AP2.0226 AP2.0233 AP2.0235 AP2.0236 AP2.0237 AP2.0238 AP2.0239 AP2.0243 AP2.0244 AP2.0245 AP2.0247 AP2.0249 AP2.0251 AP2.0252 AP2.0253 AP2.0257 AP2.0267 AP2.0269 AP2.0271 AP2.0272 AP2.0273 AP2.0279 AP2.0280 AP2.0281 AP2.0282 AP2.0284 AP2.0287 AP2.0288 AP2.0301 AP2.0305 AP2.0307 AP2.0309 AP2.0312 AP2.0315 AP2.0327 AP2.0333 AP2.0337 AP2.0341 AP2.0342 AP2.0343 AP2.0345 AP2.0351 AP2.0355 AP2.0357 AP2.0358 AP2.0370 AP2.0371 AP2.0399 AP2.0407 AP2.0409 AP2.0426 AP2.0457 AP2.0474 AP2.0475 AP2.0476 AP2.0486 AP2.0491 AP2.0494 AP2.0498 AP2.0503 AP2.0506 AP2.0509 AP2.0512 AP2.0554 AP2.0563 APT.0009C APT.0058C APT.0065C APT.0093C APT.0125C APT.0091C  
Recalling Firm/
Manufacturer		 Inpeco S.A.
Via San Gottardo 10
Lugano Switzerland
Manufacturer Reason
for Recall		 The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.
FDA Determined
Cause 2		 Software design
Action On September 10, 2021, the firm distributed "Urgent IVD Medical Device Correction" letters to affected consignees. Distributors were instructed to forward the recall communication to downstream customers. Customers were informed that the potential risk associated with the issue is related to an incorrect patient result that may lead to incorrect patient treatment. Users were provided with detailed instructions on precautions to avoid the occurrence of the described issue, including a daily visual check and what to do in case of error 3160 or 0D60. Contact your local technical support provider if you need assistance implementing these actions. Your service provider will contact you to schedule the firmware upgrade of the Automation System Interface Module to ADVIA Centaur XP/XPT. Until then, please maintain awareness of this recall and follow precautions provided by the firm. If you have any questions about this recall, please contact Eva Balzarotti, Regulatory Affairs Manager at Regulatory.Affairs@inpeco.com. Phone number: (+41) 91 9118 224.
Quantity in Commerce 262 total, 52 US
Distribution Domestic distribution nationwide . Foreign distribution worldwide.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CEM and Original Applicant = INPECO S.P.A.
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